NCT06462404

A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1

A Randomized, Double-Blind, Single-Dose, 5-Period Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Subjects With Narcolepsy Type 1

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of excessive daytime sleepiness (EDS) as assessed by the Maintenance of Wakefulness Test (MWT) in adult participants with narcolepsy type 1 (NT1).

Conditions

• Narcolepsy Type 1 (NT1)

Interventions

Type	Name	Description
DRUG	E2086	E2086 oral tablets.
DRUG	E2086 Placebo	E2086 matching placebo tablet.
DRUG	Active Comparator	Active comparator oral tablets.
DRUG	Active Comparator Placebo	Active comparator matching placebo tablet.

Timeline

• Start date: 2024-06-20
• Primary completion: 2025-03-17
• Completion: 2025-03-17
• First posted: 2024-06-17
• Last updated: 2025-06-04

Locations

14 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study